ShotblockerSHOTBLOCKERNCT06956066
The Effect of SHOTBLOCKER
A study testing shotblocker in people with Shotblocker and Injection Pain Prevention, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a randomized controlled experimental cross over study to examine the effect of injection pain, anxiety and comfort level with the use of Shotblocker in geriatric patients undergoing subcutaneous injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shotblocker, Injection Pain Prevention, Pain
- What is being tested?
- shotblocker
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2023to 21 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participants in the study, Over 65 years of age, Cognitive ability to answer the questions, Body Mass Index (BMI) 18.5- 29.9 kg / m2, No communication problems, Subcutaneous injection in the treatment, No bleeding coagulation disorder, Platelet, INR and APTT values within normal limits, No scar tissue, incision or infection findings in the injection area, No history of allergy
Who cannot join
- Patients with amputation in the right/left arm area to be studied, Patients with any scar tissue, incision, lipodystrophy or signs of infection in the injection area in the arm area, Patients receiving hemodialysis treatment and having a dialysis catheter, Patients who underwent mastectomy surgery and should not undergo any application/treatment on the arm on the operated side were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF SUBCUTANEOUS "SHOTBLOCKER" ON INJECTION PAIN, ANXIETY AND COMFORT LEVEL IN GERIATRIC PATIENTS
This study was conducted as a randomized controlled experimental cross over study to examine the effect of injection pain, anxiety and comfort level with the use of Shotblocker in geriatric patients undergoing subcutaneous injection. The study was defined on 80 patients who were inpatients in the internal wards of a hospital, and the experimental and control groups, which provided the appropriate conditions for the study, included the same people. Ethics committee approval, institutional permission and written informed consent forms were obtained from the individuals. Data were obtained by the researcher using Personal Information Form, Visual Analog Scale (VAS), State and Trait Anxiety Scale, Comfort Scale, Visual Patient Satisfaction Scale and Shotblocker.
Read the detailed description
This study was conducted as a randomized controlled experimental cross over study to examine the effect of injection pain, anxiety and comfort level with the use of Shotblocker in geriatric patients undergoing subcutaneous injection. The study was defined on 80 patients who were inpatients in the internal wards of a hospital, and the experimental and control groups, which provided the appropriate conditions for the study, included the same people. Ethics committee approval, institutional permission and written informed consent forms were obtained from the individuals. Data were obtained by the researcher using Personal Information Form, Visual Analog Scale (VAS), State and Trait Anxiety Scale, Comfort Scale, Visual Patient Satisfaction Scale and Shotblocker.
- Conditions
- Shotblocker, Injection Pain Prevention, Pain, Anxiety
- Being tested
- shotblocker
- Keywords
- Shotblocker, injection, pain, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shotblockerBiological
SHOTBLOCKER Shotblocker is a drug-free and non-invasive plastic device for all age groups that is placed during injection to press against the site of administration. It has standardized dimensions and is designed in a small, flat, horseshoe (U) shape with several blunt points on one surface in direct contact with the skin.
| Study group | Role | What they receive |
|---|---|---|
| shotblocker | Experimental | injection with shotblocker Receives: Biological: shotblocker |
| Control | No intervention | Normal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory
- Beck Anxiety Inventory Description: It is a Likert-type scale consisting of 21 items and scored between 0-3. According to scale scoring; 8 points: No anxiety, 8-15 points: Mild anxiety, 16-25 points: Moderate anxiety, 26-63 points: Determined as severe anxiety decrease the15 points
Measured: Time Frame: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start21 Dec 2023
- Primary completion23 Nov 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShotblockerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Assuming a power of 80% and an α risk of. 05, a sample size of 75 was determined to be appropriate. Considering the possibility of missing data, the study initially included 80 participants in both the experimental and control groups. A computer-based random number generator was used for group assignment, and allocation concealment was ensured by using sealed envelopes containing random numbers opened by a separate researcher. The study was completed with 40 participants in the experimental group and 40 in the control group, due to some participants withdrawing.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Dincer, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956066
- Sponsor's protocol ID
- IstanbulMU
- Acronym
- SHOTBLOCKER
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF SUBCUTANEOUS "SHOTBLOCKER" ON INJECTION PAIN, ANXIETY AND COMFORT LEVEL IN GERIATRIC PATIENTS
- ClinicalTrials.gov ID
- NCT06956066
- Acronym / sponsor ID
- SHOTBLOCKER / IstanbulMU
- Conditions
- Shotblocker, Injection Pain Prevention, Pain, Anxiety
- Keywords
- Shotblocker, injection, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 23 Nov 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted as a randomized controlled experimental cross over study to examine the effect of injection pain, anxiety and comfort level with the use of Shotblocker in geriatric patients undergoing subcutaneous injection. The study was defined on 80 patients who were inpatients in the internal wards of a hospital, and the experimental and control groups, which provided the appropriate conditions for the study, included the same people. Ethics committee approval, institutional permission and written informed consent forms were obtained from the individuals. Data were obtained by the researcher using Personal Information Form, Visual Analog Scale (VAS), State and Trait Anxiety Scale, Comfort Scale, Visual Patient Satisfaction Scale and Shotblocker.
Detailed description
This study was conducted as a randomized controlled experimental cross over study to examine the effect of injection pain, anxiety and comfort level with the use of Shotblocker in geriatric patients undergoing subcutaneous injection. The study was defined on 80 patients who were inpatients in the internal wards of a hospital, and the experimental and control groups, which provided the appropriate conditions for the study, included the same people. Ethics committee approval, institutional permission and written informed consent forms were obtained from the individuals. Data were obtained by the researcher using Personal Information Form, Visual Analog Scale (VAS), State and Trait Anxiety Scale, Comfort Scale, Visual Patient Satisfaction Scale and Shotblocker.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Assuming a power of 80% and an α risk of. 05, a sample size of 75 was determined to be appropriate. Considering the possibility of missing data, the study initially included 80 participants in both the experimental and control groups. A computer-based random number generator was used for group assignment, and allocation concealment was ensured by using sealed envelopes containing random numbers opened by a separate researcher. The study was completed with 40 participants in the experimental group and 40 in the control group, due to some participants withdrawing.
| Arm | Type | Receives |
|---|---|---|
| shotblocker | Experimental | Biological: shotblockerinjection with shotblocker |
| Control | No intervention | –Normal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Voluntary participants in the study, Over 65 years of age, Cognitive ability to answer the questions, Body Mass Index (BMI) 18.5- 29.9 kg / m2, No communication problems, Subcutaneous injection in the treatment, No bleeding coagulation disorder, Platelet, INR and APTT values within normal limits, No scar tissue, incision or infection findings in the injection area, No history of allergy
Key exclusion criteria (1 listed)
- Patients with amputation in the right/left arm area to be studied, Patients with any scar tissue, incision, lipodystrophy or signs of infection in the injection area in the arm area, Patients receiving hemodialysis treatment and having a dialysis catheter, Patients who underwent mastectomy surgery and should not undergo any application/treatment on the arm on the operated side were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shotblockerSHOTBLOCKER Shotblocker is a drug-free and non-invasive plastic device for all age groups that is placed during injection to press against the site of administration. It has standardized dimensions and is designed in a small, flat, horseshoe (U) shape with several blunt points on one surface in direct contact with the skin. | Biological | shotblocker |
Primary outcome
Beck Anxiety Inventory
Time frame: Time Frame: up to 1 day
1. Beck Anxiety Inventory Description: It is a Likert-type scale consisting of 21 items and scored between 0-3. According to scale scoring; 8 points: No anxiety, 8-15 points: Mild anxiety, 16-25 points: Moderate anxiety, 26-63 points: Determined as severe anxiety decrease the15 points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
Related trials for Shotblocker
Recruiting
ShotBlocker During Intramuscular Injection Randomized Control Trial
Neonatal Pain
Not yet recruiting
The Effect of ShotBlocker on Symptoms of Pain, Anxiety, and Cortisol Hormone Levels
Pain, Anxiety
Recruiting
Effect of Vibration and ShotBlocker on Pain and Fear Levels During Intramuscular Injection in Children in the Emergency Department
Children, Pain Management
Enrolling by invitation
The Effect of ShotBlocker and Finger Puppet on Pain and Fear During Blood Drawing in Children
Pain, Fear
Recruiting
Non-Pharmacological Methods in Heel Lance
Heel Lance Procedures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shotblocker in people with Shotblocker and Injection Pain Prevention, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Inventory (time frame: Time Frame: up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.